IceSphere™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: IceSphere™ FDA UDI
Generic Name: Cryosurgical set FDA UDI
Device Name: Cryoablation Needle FDA UDI
Model / Reference: H7493968435730 FDA UDI
Description: Cryoablation Needle FDA UDI

Identifiers

Catalog Number: H7493968435730 FDA UDI
Primary DI / UDI-DI: 00191506055769 FDA UDI
FDA Product Code: GEH FDA UDI
GMDN Term: Cryosurgical set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 175 Millimeter FDA UDI
Needle Gauge — 17 Gauge FDA UDI

Category: Cryosurgical set

IceSphere™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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V2 ICE Probe SL — SANARUS TECHNOLOGIES, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 7b6f95ee-ffc2-46da-918b-93e91e76fe28 35 fields · synced May 30, 2026